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List of Drug Master Files (DMF) of Balsalazide Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Axplora (1)

02 Ajinomoto Company (2)

03 Chifeng Arker Pharmaceutical Technology Co. Ltd. (1)

04 Corden Pharma Bergamo S.p.A (1)

05 Formosa Laboratories (1)

06 Ipca Laboratories (1)

07 Olon S.p.A (1)

08 Signa S.A. de C.V. (1)

09 Blank (1)

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01 BALSALAZIDE DISODIUM (4)

02 BALSALAZIDE DISODIUM DIHYDRATE (3)

03 BALSALAZIDE DISODIUM DIHYDRATE USP (2)

04 BALSALAZIDE DISODIUM SALT (1)

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01 China (1)

02 Germany (1)

03 India (1)

04 Italy (2)

05 Japan (2)

06 Mexico (1)

07 Taiwan (1)

08 Blank (1)

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01 Active (3)

02 Inactive (7)

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01 Complete (3)

02 Blank (7)

16425
Active
2003-02-17
Complete
2021-08-10
2021-08-06
II
Axplora CB

RDD 2024

Not Confirmed

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16256
Inactive
2003-01-02
N/A
II
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12287
Inactive
1996-12-20
N/A
II
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18573
Inactive
2005-05-07
N/A
II
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17500
Inactive
2004-06-25
N/A
II
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17326
Active
2004-04-19
Complete
2013-08-07
2013-07-30
II
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17780
Inactive
2004-10-20
N/A
II
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19684
Inactive
2006-08-03
N/A
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18894
Active
2005-10-21
Complete
2014-06-24
2013-04-30
II
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COURTAULDS CHEMICALS

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12289
Inactive
1996-12-18
N/A
II
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Looking for 82101-18-6 / Balsalazide Disodium API manufacturers, exporters & distributors?

Balsalazide Disodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Balsalazide Disodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Balsalazide Disodium manufacturer or Balsalazide Disodium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Balsalazide Disodium manufacturer or Balsalazide Disodium supplier.

PharmaCompass also assists you with knowing the Balsalazide Disodium API Price utilized in the formulation of products. Balsalazide Disodium API Price is not always fixed or binding as the Balsalazide Disodium Price is obtained through a variety of data sources. The Balsalazide Disodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Balsalazide Disodium

Synonyms

Colazal, 213594-60-6, 82101-18-6, Balsalazide sodium, Colazide, Bx-661a

Cas Number

82101-18-6

Unique Ingredient Identifier (UNII)

15ASW03C9S

About Balsalazide Disodium

Balsalazide Disodium is the disodium salt form of balsalazide, an aminosalicylate and oral prodrug that is enzymatically cleaved in the colon to produce the anti-inflammatory agent mesalazine. Mesalazine acts locally on the mucosa of the colon where it diminishes inflammation by blocking the production of arachidonic acid metabolites, including leukotrienes, prostaglandins and hydroxyeicosatetraenoic acids, and other inflammatory agents. Balsalazide disodium is used to treat chronic inflammatory bowel disease.

Balsalazide Manufacturers

A Balsalazide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Balsalazide, including repackagers and relabelers. The FDA regulates Balsalazide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Balsalazide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Balsalazide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Balsalazide Suppliers

A Balsalazide supplier is an individual or a company that provides Balsalazide active pharmaceutical ingredient (API) or Balsalazide finished formulations upon request. The Balsalazide suppliers may include Balsalazide API manufacturers, exporters, distributors and traders.

click here to find a list of Balsalazide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Balsalazide USDMF

A Balsalazide DMF (Drug Master File) is a document detailing the whole manufacturing process of Balsalazide active pharmaceutical ingredient (API) in detail. Different forms of Balsalazide DMFs exist exist since differing nations have different regulations, such as Balsalazide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Balsalazide DMF submitted to regulatory agencies in the US is known as a USDMF. Balsalazide USDMF includes data on Balsalazide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Balsalazide USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Balsalazide suppliers with USDMF on PharmaCompass.

Balsalazide Manufacturers | Traders | Suppliers

Balsalazide Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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